SOOLANTRA
Generic: IVERMECTIN
Basic Information
Manufacturer
Galderma Laboratories, L.P.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
b1d5b166-ab06-4ab5-b0c6-31126238118a
Indications & Usage
1 INDICATIONS AND USAGE SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.
SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.
( 1 )
SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS In controlled clinical trials with SOOLANTRA cream the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P.
at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 2047 subjects with inflammatory lesions of rosacea received SOOLANTRA cream once daily.
A total of 1555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year.
Adverse reactions, reported in ≤ 1% of subjects treated with SOOLANTRA cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local adverse reactions: contact dermatitis and allergic dermatitis.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P.
at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 2047 subjects with inflammatory lesions of rosacea received SOOLANTRA cream once daily.
A total of 1555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year.
Adverse reactions, reported in ≤ 1% of subjects treated with SOOLANTRA cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local adverse reactions: contact dermatitis and allergic dermatitis.